RX Herculink Elite Renal and Biliary Stent System

FDA Premarket Approval P110001 S016

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

A change to the resin supplier for material used in the inner member subassembly of the rx herculink elite renal and biliary stent system

DeviceRX Herculink Elite Renal and Biliary Stent System
Generic NameStent, Renal
ApplicantABBOTT VASCULAR
Date Received2021-09-28
Decision Date2021-10-26
PMAP110001
SupplementS016
Product CodeNIN 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR 3200 Lakeside Drive santa Clara, CA 95054

Supplemental Filings

Supplement NumberDateSupplement Type
P110001Original Filing
S016 2021-09-28 30-day Notice
S015 2021-04-29 30-day Notice
S014 2021-04-29 30-day Notice
S013 2017-03-21 30-day Notice
S012 2015-02-25 30-day Notice
S011 2013-12-11 Normal 180 Day Track No User Fee
S010 2012-12-19 30-day Notice
S009 2012-08-02 Normal 180 Day Track No User Fee
S008 2012-07-20 30-day Notice
S007 2012-06-13 30-day Notice
S006 2012-06-11 30-day Notice
S005 2012-05-24 30-day Notice
S004 2012-05-11 30-day Notice
S003 2012-04-27 Normal 180 Day Track No User Fee
S002 2011-11-21 30-day Notice
S001 2011-08-19 30-day Notice

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